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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003885-11 | EudraCT Number | ||
| MAGNETISMM-4; Umbrella Study | Other Identifier | Alias Study Number |
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A business decision was made by Pfizer to terminate the study and not proceed with the Phase 2 expansion of this study. The reason for study termination is not due to any safety concerns or requests from regulatory authorities.
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The purpose of this study is to determine the Recommended Phase 2 Dose and clinical benefit of elranatamab in combination with other anti-cancer therapies in participants with multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sub-Study A | Experimental | BCMA-CD3 bispecific antibody + gamma secretase inhibitor |
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| Sub-Study B | Experimental | BCMA-CD3 bispecific antibody + immunomodulatory drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elranatamab + Nirogacestat | Drug | BCMA-CD3 bispecific antibody + gamma secretase inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| SSA: Number of Participants With Dose Limiting Toxicities (DLTs)- Phase 1b Dose Escalation | DLT- Hematological:Grade (G)4 neutropenia >5 days; febrile neutropenia; G>=3 neutropenia, infection; G4 thrombocytopenia; G3 thrombocytopenia and G>=2 bleeding. Non-hematological: G>=4 adverse events(AEs); G3 cytokine release syndrome(CRS) [except CRS not been maximally treated or improved to G<=1 in 48 hours]; G3 AEs (except AEs attributed to CRS, G3 nausea, vomiting, diarrhea that improve to G2<=72 hours after maximal medical management has been initiated, G3 fatigue < 1 week); confirmed drug-induced liver injury meeting Hy's law criteria; G3-4 laboratory abnormalities(except not associated with clinical sequelae and improve to G=<2 in 72 hours); G2 clinically important/persistent AEs(cause significant dose delay/reduction) may be DLT; G3 injection site reaction, allergic reaction, anaphylaxis. Common Terminology Criteria for Adverse Events(CTCAE) version 5.0: G1:mild AE, G2:moderate, G3:severe, G4:life-threatening consequences; urgent intervention indicated, G5:death related to AE. | From Cycle 0 Day 1 through Cycle 1 Day 28 (approximately up to 35 days) |
| SSB: Number of Participants With DLTs- Phase 1b | Hematological: G4 neutropenia >5 days; febrile neutropenia; G>=3 neutropenia with infection; G4 thrombocytopenia; G3 thrombocytopenia with G>=2 bleeding. Non-hematological: G>=4 AEs; G3 CRS (except CRS events: not been maximally treated or improved to grade <=1 within 48 hours); G3 AEs (except: AEs attributed to CRS, G3 nausea, vomiting and diarrhea that improve to G2<=72 hours after maximal medical management has been initiated, G3 fatigue < 1 week); confirmed drug-induced liver injury meeting Hy's law criteria; G 3-4 laboratory abnormalities (except: not associated with clinical sequelae and improve to G=<2 within 72 hours); Other clinically important/persistent AEs (that cause significant dose delay/reduction) may be DLT; G3 injection site reaction. CTCAE version 5.0: G1: Mild AE, G2: Moderate, G3: Severe, G4: Life-threatening consequences; urgent intervention indicated, G5: Death related to AE. | From Cycle 0 Day 1 through Cycle 1 Day 28 (approximately up to 42 days) |
| Measure | Description | Time Frame |
|---|---|---|
| SSA: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Related TEAEs- Phase 1b | An adverse event was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention, including both serious and all non-serious adverse events. A serious adverse event (SAE): any untoward medical occurrence that, at any dose resulting in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. Relatedness of any AE to treatment to be judged by investigator. |
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Inclusion Criteria:
Relapsed/refractory multiple myeloma with at least 3 prior lines of therapy
Refractory to at least one IMiD, one proteasome inhibitor, and one anti-CD38 antibody
Measurable disease defined by at least one of the following:
ECOG performance status 0 -1
Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade \
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Gateway Medical Center | Gilbert | Arizona | 85234 | United States | ||
| Banner Gateway Medical Pavilion |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Outcome measures data are reported at Primary Completion Date, and data is disclosed for only those outcome measures whose analysis were final. Remaining outcome measures' data would be reported upon their complete analyses at study completion date. Safety summaries reported are until October 2025 (approximately up to 48 months).
A total of 46 participants were enrolled in this study. Study had two sub-studies: sub-study A (SSA) and sub-study B (SSB). Phase 1b and Phase 2 were planned for SSA, while Phase 1b for SSB. Phase 2 of SSA was not conducted, based on sponsor's decision. Hence there is no data reported for Phase 2 in any section of the results' record.
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| ID | Title | Description |
|---|---|---|
| FG000 | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 1 | Participants with relapsed/refractory multiple myeloma (RRMM) received elranatamab 4 milligram (mg) subcutaneously (SC) on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) [priming dose] and thereafter 4 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally twice a day (BID). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 31, 2023 | Jan 22, 2026 |
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| Elranatamab + lenalidomide + dexamethasone | Drug | BCMA-CD3 bispecific antibody + immunomodulatory |
|
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| From treatment initiation till study completion |
| SSA: Number of Participants With Severity of AEs According to Cytokine Release Syndrome (CRS) Graded According to American Society for Transplantation and Cellular Therapy (ASTCT) Grading Criteria 2019- Phase 1b | CRS: supraphysiologic response following any immune therapy that results in the activation or engagement of endogenous or infused T-cells and/or other immune effector cells. Symptoms must include fever at the onset, and may include hypotension, hypoxia and end organ dysfunction. As per ASTCT criteria, G1: fever (temperature >=38 degree Celsius), hypotension and/or hypoxia none; G2: fever, hypotension not requiring vasopressors, hypoxia requiring low-flow nasal cannula/facemask or blow-by; G3: fever, hypotension requiring a vasopressor with or without vasopressin, hypoxia requiring high-flow nasal cannula/facemask, nonrebreather mask, or Venturi mask; G4: fever, hypotension requiring multiple vasopressors (excluding vasopressin), hypoxia requiring positive pressure. Organ toxicities associated with CRS graded according to CTCAE v5.0. G1: mild, G2: moderate, G3: severe, G4: life-threatening consequences; urgent intervention indicated. G5: death related to AE. | From treatment initiation till study completion |
| SSA: Number of Participants With Severity of AEs According to Immune Effector Cell-associated Neurotoxicity Syndrome ICANS Graded According to ASTCT Grading Criteria 2019- Phase 1b | ASTCT for ICANS [immune effector cell-associated encephalopathy (ICE, overall score range 0-10, higher score = better condition). G1: ICE score 7-9, awakens spontaneously; G2: ICE score 3-6, awakens to voice; G3: ICE score 0-2, awakens only to tactile stimulus, any clinical seizure that resolves rapidly or non-convulsive seizures on electroencephalography that resolve with intervention, focal/local oedema on neuroimaging; G4: ICE score 0 (unarousable and unable to perform ICE), unarousable or requires vigorous or repetitive tactile stimuli to arouse. Stupor or coma, life-threatening prolonged seizure (>5 min); or repetitive clinical or electrical seizures without return to baseline in between, deep focal motor weakness such as hemiparesis or paraparesis, diffuse cerebral oedema on neuroimaging; decerebrate or decorticate posturing; or cranial nerve VI (abducens nerve) palsy; or papilledema; or Cushing's triad; G5: death.](streamdown:incomplete-link) | From treatment initiation till study completion |
| SSA: Number of Participants With Laboratory Abnormalities- Phase 1b | Number of participants with laboratory abnormalities will be reported in this outcome measure. | From treatment initiation till study completion |
| SSA: Objective Response Rate (ORR) as Per International Myeloma Working Group (IMWG) Criteria as Determined by Investigator- Phase 1b | ORR: % of participants with objective response. Stringent complete response(sCR): CR & normal serum free light chain (sFLC) ratio &absence of clonal cells in BMB/BMA by immunohistochemistry or immunofluorescence. CR: negative immunofixation on serum &urine, disappearance of soft tissue plasmacytomas &<5% plasma cells in BMA. If disease measurable by sFLC only, preceding criteria &normal sFLC ratio. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum M-protein & urine M-protein level <100 mg/24h; PR: >=50% reduction of serum M-protein & reduction in 24h urinary M-protein by >=90% or to <200 mg/24 hours (If disease measurable by sFLC only: VGPR & PR: >=90% &>=50% decrease in difference respectively between involved & uninvolved sFLC levels). In addition, if present at baseline, VGPR & PR: >=90% &>=50% reduction compared with baseline in soft tissue plasmacytomas' size. | From treatment initiation till study completion |
| SSA: Complete Response Rate (CRR) as Per IMWG Criteria as Determined by Investigator- Phase 1b | CRR was defined as the percentage of participants with a Best Overall Response (BOR) of confirmed sCR/CR per IMWG response criteria as determined by investigator. sCR: i) CR; ii) normal serum FLC ratio and absence of clonal cells in BMB/BMA by immunohistochemistry or immunofluorescence (κ/λ ratio <=4:1 or >=1:2 for κ and λ participants, respectively, after counting >=100 plasma cells; iii) if the only measurable disease was by serum FLC levels, sCR was defined as normal serum FLC ratio of 0.26 to 1.65 plus absence of clonal cells in BMB/BMA b by immunohistochemistry or immunofluorescence (κ/λ ratio <=4:1 or >=1:2 for κ and λ participants, respectively, after counting >=100 plasma cells). CR: i) negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in BMA; ii) if the only measurable disease was by serum FLC levels, CR was defined as normal serum FLC ratio of 0.26 to 1.65 plus criteria (i). | From treatment initiation till study completion |
| SSA: Time to Response (TTR) as Per IMWG Criteria as Determined by Investigator-Phase 1b | TTR was defined, for participants with an objective response per IMWG criteria, as the time from the date of first dose to the first documentation of objective response that is subsequently confirmed. | From treatment initiation till study completion |
| SSA: Duration of Response (DOR) as Per IMWG Criteria as Determined by Investigator- Phase 1b | DOR (for participants (pts) with objective response (OR) per IMWG)=time from the first OR that is confirmed (conf), until conf PD per IMWG, or death due to any cause, whichever occurred first. PD=any of: (i)Increase (inc) >=25% from lowest conf response value of (a)Serum M-component (absolute (abs) inc >=0.5 g/dL) (b)Serum M-protein inc >=1 g/dL if lowest M component >=5 g/dL (c)Urine M-protein (abs inc >=200 mg/24 h) (d)in pts without measurable (meas) serum and urine M-protein levels, difference between involved and uninvolved serum FLC levels (abs inc >10 mg/dL) (e)in pts without meas serum and urine M-protein levels and without meas involved serum FLC, bone marrow plasma-cell (PC) percentage irrespective of baseline status (abs inc >=10%) (ii)appearance of new lesion(s), >=50% inc from nadir in SPD of >1 lesion, or >= 50% inc in longest diameter of a prior lesion >1 cm in short axis (iii)>=50% inc in circulating PC (minimum 200 cells per microliter) if the only measure of disease. | From treatment initiation till study completion |
| SSA: Duration of Complete Response (DOCR) as Per IMWG Criteria as Determined by Investigator- Phase 1b | DOCR (for participants (pts) with CR/sCR per IMWG)= time from the first CR/sCR that is confirmed (conf), until conf PD per IMWG, or death due to any cause, whichever occurred first. PD=any of: (i)Increase (inc) >=25% from lowest conf response value of (a)Serum M-component (absolute (abs) inc >=0.5 g/dL) (b)Serum M-protein inc >=1 g/dL if lowest M component >=5 g/dL (c)Urine M-protein (abs inc >=200 mg/24 h) (d)in pts without measurable (meas) serum and urine M-protein levels, difference between involved and uninvolved serum FLC levels (abs inc >10 mg/dL) (e)in pts without meas serum and urine M-protein levels and without meas involved serum FLC, bone marrow plasma-cell (PC) percentage irrespective of baseline status (abs inc >=10%) (ii)appearance of new lesion(s), >=50% inc from nadir in SPD of >1 lesion, or >= 50% inc in longest diameter of a prior lesion >1 cm in short axis (iii)>=50% inc in circulating PC (minimum 200 cells per microliter) if the only measure of disease. | From treatment initiation till study completion |
| SSA: Progression Free Survival (PFS) as Per IMWG Criteria as Determined by Investigator- Phase 1b | PFS=time from date of first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first. PD=any of: (i)Increase (inc) >=25% from lowest confirmed response value of (a)Serum M-component (absolute (abs) inc >=0.5 g/dL) (b)Serum M-protein inc >=1 g/dL if lowest M component >=5 g/dL (c)Urine M-protein (abs inc >=200 mg/24 h) (d)in pts without measurable (meas) serum and urine M-protein levels, difference between involved and uninvolved serum FLC levels (abs inc >10 mg/dL) (e)in pts without meas serum and urine M-protein levels and without meas involved serum FLC, bone marrow plasma-cell (PC) percentage irrespective of baseline status (abs inc >=10%) (ii)appearance of new lesion(s), >=50% inc from nadir in SPD of >1 lesion, or >= 50% inc in longest diameter of a previous lesion >1 cm in short axis (iii)>=50% inc in circulating PC (minimum 200 cells per microliter) if the only measure of disease. | From treatment initiation till study completion |
| SSA: Overall Survival (OS)- Phase 1b | OS was defined as the time from the first date of the study intervention to the date of death due to any cause. Participants not known to have died are censored on the date of last known alive. | From treatment initiation till study completion |
| SSA: Minimal Residual Disease (MRD) Negativity Rate as Per IMWG Criteria- Phase 1b | MRD negativity rate is defined as the proportion of participants with CR or better by investigator and negative MRD (assessed by central lab) per IMWG sequencing criteria at any time from the date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy, whichever occurs first. 1) CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in BMA. If the only measurable disease is by serum FLC levels, CR was defined as normal serum FLC ratio of 0.26 to 1.65; 2) Sequencing MRD-negative: Absence of clonal plasma cells by next generation sequencing (NGS) on BMA in which presence of a clone was defined as <2 identical sequencing reads obtained after DNA sequencing of BMA using the LymphoSIGHT platform (or validated equivalent method) with a minimum sensitivity of 1 in 10^5 nucleated cells. | From treatment initiation till study completion |
| SSA: Pre- and Post-dose Concentrations of Elranatamab- Phase 1b | From treatment initiation till study completion |
| SSA: Trough Serum Concentrations of Nirogacestat- Phase 1b | From treatment initiation till study completion |
| SSA: Number of Participants With Anti-drug Antibodies (ADA)- Phase 1b | From treatment initiation till study completion |
| SSA: Number of Participants With Neutralizing Antibodies (NAb)- Phase 1b | From treatment initiation till study completion |
| SSB: Number of Participants With TEAEs and Treatment Related TEAEs- Phase 1b | AE: any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention, including both serious and all non-serious adverse events. A SAE: any untoward medical occurrence that, at any dose resulting in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. Relatedness of any AE to treatment to be judged by investigator. | From treatment initiation till study completion |
| SSB: Number of Participants With Severity of Adverse Events According to CRS Graded According to ASTCT Grading Criteria 2019- Phase 1b Dose Escalation | CRS: supraphysiologic response following any immune therapy that results in the activation or engagement of endogenous or infused T-cells and/or other immune effector cells. Symptoms must include fever at the onset, and may include hypotension, hypoxia and end organ dysfunction. As per ASTCT criteria, G1: fever (temperature >=38 degree Celsius), hypotension and/or hypoxia none; G2: fever, hypotension not requiring vasopressors, hypoxia requiring low-flow nasal cannula/facemask or blow-by; G3: fever, hypotension requiring a vasopressor with or without vasopressin, hypoxia requiring high-flow nasal cannula/facemask, nonrebreather mask, or Venturi mask; G4: fever, hypotension requiring multiple vasopressors (excluding vasopressin), hypoxia requiring positive pressure. Organ toxicities associated with CRS graded according to CTCAE v5.0. G1: mild, G2: moderate, G3: severe, G4: life-threatening consequences; urgent intervention indicated. G5: death related to AE. | From treatment initiation till study completion |
| SSB: Number of Participants With Severity of Adverse Events According to ICANS Graded According to ASTCT Grading Criteria 2019- Phase 1b Dose Escalation | ASTCT for ICANS (ICE, overall score range 0-10, higher score = better condition). G1: ICE score 7-9, awakens spontaneously; G2: ICE score 3-6, awakens to voice; G3: ICE score 0-2, awakens only to tactile stimulus, any clinical seizure that resolves rapidly or non-convulsive seizures on electroencephalography that resolve with intervention, focal/local oedema on neuroimaging; G4: ICE score 0 (unarousable and unable to perform ICE), unarousable or requires vigorous or repetitive tactile stimuli to arouse. Stupor or coma, life-threatening prolonged seizure (>5 min); or repetitive clinical or electrical seizures without return to baseline in between, deep focal motor weakness such as hemiparesis or paraparesis, diffuse cerebral oedema on neuroimaging; decerebrate or decorticate posturing; or cranial nerve VI (abducens nerve) palsy; or papilledema; or Cushing's triad; G5: death. | From treatment initiation till study completion |
| SSB: Number of Participants With Laboratory Abnormalities- Phase 1b Dose Escalation | Number of participants with laboratory abnormalities will be reported in this outcome measure. | From treatment initiation till study completion |
| SSB: ORR as Per IMWG Criteria as Determined by Investigator- Phase 1b Dose Escalation | ORR: % of participants with objective response. sCR: CR & normal sFLC ratio and absence of clonal cells in BMB/BMA by immunohistochemistry or immunofluorescence. CR: negative immunofixation on serum and urine, disappearance of soft tissue plasmacytomas &<5% plasma cells in BMA. If disease measurable by sFLC only, preceding criteria &normal sFLC ratio. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum M-protein & urine M-protein level <100 mg/24h; PR: >=50% reduction of serum M-protein & reduction in 24h urinary M-protein by >=90% or to <200 mg/24 hours (If disease measurable by sFLC only: VGPR & PR: >=90% &>=50% decrease in difference respectively between involved & uninvolved sFLC levels). In addition, if present at baseline, VGPR & PR: >=90% &>=50% reduction compared with baseline in soft tissue plasmacytomas' size. | From treatment initiation till study completion |
| SSB: CRR as Per IMWG Criteria as Determined by Investigator- Phase 1b Dose Escalation | CRR was defined as the percentage of participants with a BOR of confirmed sCR/CR per IMWG response criteria as determined by investigator. sCR: i) CR; ii) normal serum FLC ratio and absence of clonal cells in BMB/BMA by immunohistochemistry or immunofluorescence (κ/λ ratio <=4:1 or >=1:2 for κ and λ participants, respectively, after counting >=100 plasma cells; iii) if the only measurable disease was by serum FLC levels, sCR was defined as normal serum FLC ratio of 0.26 to 1.65 plus absence of clonal cells in BMB/BMA b by immunohistochemistry or immunofluorescence (κ/λ ratio <=4:1 or >=1:2 for κ and λ participants, respectively, after counting >=100 plasma cells). CR: i) negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in BMA; ii) if the only measurable disease was by serum FLC levels, CR was defined as normal serum FLC ratio of 0.26 to 1.65 plus criteria (i). | From treatment initiation till study completion |
| SSB: TTR as Per IMWG Criteria as Determined by Investigator- Phase 1b Dose Escalation | TTR was defined for participants with an objective response per IMWG criteria, as the time from the date of first dose to the first documentation of objective response that is subsequently confirmed. | From treatment initiation till study completion |
| SSB: DOR as Per IMWG Criteria as Determined by Investigator- Phase 1b Dose Escalation | DOR (for participants (pts) with objective response (OR) per IMWG)=time from the first OR that is confirmed (conf), until conf PD per IMWG, or death due to any cause, whichever occurred first. PD=any of: (i)Increase (inc) >=25% from lowest conf response value of (a)Serum M-component (absolute (abs) inc >=0.5 g/dL) (b)Serum M-protein inc >=1 g/dL if lowest M component >=5 g/dL (c)Urine M-protein (abs inc >=200 mg/24 h) (d)in pts without measurable (meas) serum and urine M-protein levels, difference between involved and uninvolved serum FLC levels (abs inc >10 mg/dL) (e)in pts without meas serum and urine M-protein levels and without meas involved serum FLC, bone marrow plasma-cell (PC) percentage irrespective of baseline status (abs inc >=10%) (ii)appearance of new lesion(s), >=50% inc from nadir in SPD of >1 lesion, or >= 50% inc in longest diameter of a prior lesion >1 cm in short axis (iii)>=50% inc in circulating PC (minimum 200 cells per microliter) if the only measure of disease. | From treatment initiation till study completion |
| SSB: DOCR as Per IMWG Criteria as Determined by Investigator- Phase 1b Dose Escalation | DOCR (for participants (pts) with CR/sCR per IMWG)= time from the first CR/sCR that is confirmed (conf), until conf PD per IMWG, or death due to any cause, whichever occurred first. PD=any of: (i)Increase (inc) >=25% from lowest conf response value of (a)Serum M-component (absolute (abs) inc >=0.5 g/dL) (b)Serum M-protein inc >=1 g/dL if lowest M component >=5 g/dL (c)Urine M-protein (abs inc >=200 mg/24 h) (d)in pts without measurable (meas) serum and urine M-protein levels, difference between involved and uninvolved serum FLC levels (abs inc >10 mg/dL) (e)in pts without meas serum and urine M-protein levels and without meas involved serum FLC, bone marrow plasma-cell (PC) percentage irrespective of baseline status (abs inc >=10%) (ii)appearance of new lesion(s), >=50% inc from nadir in SPD of >1 lesion, or >= 50% inc in longest diameter of a prior lesion >1 cm in short axis (iii)>=50% inc in circulating PC (minimum 200 cells per microliter) if the only measure of disease. | From treatment initiation till study completion |
| SSB: PFS as Per IMWG Criteria as Determined by Investigator- Phase 1b Dose Escalation | PFS=time from date of first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first. PD=any of: (i)Increase (inc) >=25% from lowest confirmed response value of (a)Serum M-component (absolute (abs) inc >=0.5 g/dL) (b)Serum M-protein inc >=1 g/dL if lowest M component >=5 g/dL (c)Urine M-protein (abs inc >=200 mg/24 h) (d)in pts without measurable (meas) serum and urine M-protein levels, difference between involved and uninvolved serum FLC levels (abs inc >10 mg/dL) (e)in pts without meas serum and urine M-protein levels and without meas involved serum FLC, bone marrow plasma-cell (PC) percentage irrespective of baseline status (abs inc >=10%) (ii)appearance of new lesion(s), >=50% inc from nadir in SPD of >1 lesion, or >= 50% inc in longest diameter of a previous lesion >1 cm in short axis (iii)>=50% inc in circulating PC (minimum 200 cells per microliter) if the only measure of disease. | From treatment initiation till study completion |
| SSB: OS- Phase 1b Dose Escalation | OS was defined as the time from the first date of the study intervention to the date of death due to any cause. Participants not known to have died are censored on the date of last known alive. | From treatment initiation till study completion |
| SSB: MRD Negativity Rate as Per IMWG Criteria- Phase 1b Dose Escalation | MRD negativity rate is defined as the proportion of participants with CR or better by investigator and negative MRD (assessed by central lab) per IMWG sequencing criteria at any time from the date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy, whichever occurs first. 1) CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in BMA. If the only measurable disease is by serum FLC levels, CR was defined as normal serum FLC ratio of 0.26 to 1.65; 2) Sequencing MRD-negative: Absence of clonal plasma cells by next generation sequencing (NGS) on BMA in which presence of a clone was defined as <2 identical sequencing reads obtained after DNA sequencing of BMA using the LymphoSIGHT platform (or validated equivalent method) with a minimum sensitivity of 1 in 10^5 nucleated cells. | From treatment initiation till study completion |
| SSB: Pre- and Post-dose Concentrations of Elranatamab- Phase 1b Dose Escalation | From treatment initiation till study completion |
| SSB: Trough Serum Concentrations of Lenalidomide- Phase 1b Dose Escalation | From treatment initiation till study completion |
| SSA: Number of Participants With ADA- Phase 1b Dose Escalation | From treatment initiation till study completion |
| SSB: Number of Participants With NAb- Phase 1b Dose Escalation | From treatment initiation till study completion |
| Gilbert |
| Arizona |
| 85234 |
| United States |
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States |
| Banner Health d.b.a. Banner MD Anderson Cancer Center | Phoenix | Arizona | 85012 | United States |
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | United States |
| Clinical Research Advisors | Encino | California | 91316 | United States |
| Clinical Research Advisors | Los Angeles | California | 90020 | United States |
| Cedars Sinai Medical Center Oncology IDS Pharmacy Attn:Suwicha Limvorasak ,PharmaD | Los Angeles | California | 90048 | United States |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute (SOCCI) | Los Angeles | California | 90048 | United States |
| Clinical Research Advisors | Los Angeles | California | 90048 | United States |
| Cedars-Sinai Tarzana | Tarzana | California | 91356 | United States |
| Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center | Coral Gables | Florida | 33146 | United States |
| University of Miami | Coral Gables | Florida | 33146 | United States |
| Sylvester Comprehensive Cancer Center- Deerfield Beach | Deerfield Beach | Florida | 33442 | United States |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| UHealth Tower | Miami | Florida | 33136 | United States |
| The Johns Hopkins University School of Medicine | Baltimore | Maryland | 21205 | United States |
| OIDS, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | United States |
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Also Imaging Facility) | Baltimore | Maryland | 21231 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Arthur J.E. Child Comprehensive Cancer Centre | Calgary | Alberta | T2N 5G2 | Canada |
| The Ottawa Hospital - General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| FG001 |
| SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 2 |
Participants with RRMM received elranatamab 4 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 8 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) [priming dose] and thereafter 12 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID. |
| FG002 | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3 | Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) [priming dose] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID. |
| FG003 | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3A | Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) [priming dose] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally once daily (QD). |
| FG004 | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 4A | Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) [priming dose] and thereafter 76 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally QD. |
| FG005 | SSB, Phase 1b: Elranatamab + Lenalidomide + Dexamethasone, Dose Level 1 | Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) [priming dose] and 44 mg on Cycle 0 Day 8 and thereafter 44 mg weekly during each cycle (1 cycle = 4 weeks) and Lenalidomide 15 mg QD for 21 days and Dexamethasone 20 mg weekly on Cycle 1 and 2. |
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| ID | Title | Description |
|---|---|---|
| BG000 | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 1 | Participants with RRMM received elranatamab 4 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) [priming dose] and thereafter 4 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID. |
| BG001 | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 2 | Participants with RRMM received elranatamab 4 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 8 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) [priming dose] and thereafter 12 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID. |
| BG002 | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3 | Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) [priming dose] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID. |
| BG003 | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3A | Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) [priming dose] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally QD. |
| BG004 | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 4A | Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) [priming dose] and thereafter 76 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally QD. |
| BG005 | SSB, Phase 1b: Elranatamab + Lenalidomide + Dexamethasone, Dose Level 1 | Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) [priming dose] and 44 mg on Cycle 0 Day 8 and thereafter 44 mg weekly during each cycle (1 cycle = 4 weeks) and Lenalidomide 15 mg QD for 21 days and Dexamethasone 20 mg weekly on Cycle 1 and 2. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
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| Primary | SSA: Number of Participants With Dose Limiting Toxicities (DLTs)- Phase 1b Dose Escalation | DLT- Hematological:Grade (G)4 neutropenia >5 days; febrile neutropenia; G>=3 neutropenia, infection; G4 thrombocytopenia; G3 thrombocytopenia and G>=2 bleeding. Non-hematological: G>=4 adverse events(AEs); G3 cytokine release syndrome(CRS) [except CRS not been maximally treated or improved to G<=1 in 48 hours]; G3 AEs (except AEs attributed to CRS, G3 nausea, vomiting, diarrhea that improve to G2<=72 hours after maximal medical management has been initiated, G3 fatigue < 1 week); confirmed drug-induced liver injury meeting Hy's law criteria; G3-4 laboratory abnormalities(except not associated with clinical sequelae and improve to G=<2 in 72 hours); G2 clinically important/persistent AEs(cause significant dose delay/reduction) may be DLT; G3 injection site reaction, allergic reaction, anaphylaxis. Common Terminology Criteria for Adverse Events(CTCAE) version 5.0: G1:mild AE, G2:moderate, G3:severe, G4:life-threatening consequences; urgent intervention indicated, G5:death related to AE. | DLT evaluable analysis set included all enrolled participants who received at least 1 dose of the study intervention in the Phase 1b part of the study and either experience DLT(s) or complete the DLT observation period without DLT. Participants without DLTs who received less than the minimum requirement of the planned doses of each investigational product (IP) were not evaluable for DLTs. | Posted | Count of Participants | Participants | From Cycle 0 Day 1 through Cycle 1 Day 28 (approximately up to 35 days) |
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| Primary | SSB: Number of Participants With DLTs- Phase 1b | Hematological: G4 neutropenia >5 days; febrile neutropenia; G>=3 neutropenia with infection; G4 thrombocytopenia; G3 thrombocytopenia with G>=2 bleeding. Non-hematological: G>=4 AEs; G3 CRS (except CRS events: not been maximally treated or improved to grade <=1 within 48 hours); G3 AEs (except: AEs attributed to CRS, G3 nausea, vomiting and diarrhea that improve to G2<=72 hours after maximal medical management has been initiated, G3 fatigue < 1 week); confirmed drug-induced liver injury meeting Hy's law criteria; G 3-4 laboratory abnormalities (except: not associated with clinical sequelae and improve to G=<2 within 72 hours); Other clinically important/persistent AEs (that cause significant dose delay/reduction) may be DLT; G3 injection site reaction. CTCAE version 5.0: G1: Mild AE, G2: Moderate, G3: Severe, G4: Life-threatening consequences; urgent intervention indicated, G5: Death related to AE. | DLT evaluable analysis set included all enrolled participants who received at least 1 dose of the study intervention in the Phase 1b part of the study and either experience DLT(s) or complete the DLT observation period without DLT. Participants without DLTs who received less than the minimum requirement of the planned doses of each IP were not evaluable for DLTs. | Posted | Count of Participants | Participants | From Cycle 0 Day 1 through Cycle 1 Day 28 (approximately up to 42 days) |
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| Secondary | SSA: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Related TEAEs- Phase 1b | An adverse event was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention, including both serious and all non-serious adverse events. A serious adverse event (SAE): any untoward medical occurrence that, at any dose resulting in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. Relatedness of any AE to treatment to be judged by investigator. | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSA: Number of Participants With Severity of AEs According to Cytokine Release Syndrome (CRS) Graded According to American Society for Transplantation and Cellular Therapy (ASTCT) Grading Criteria 2019- Phase 1b | CRS: supraphysiologic response following any immune therapy that results in the activation or engagement of endogenous or infused T-cells and/or other immune effector cells. Symptoms must include fever at the onset, and may include hypotension, hypoxia and end organ dysfunction. As per ASTCT criteria, G1: fever (temperature >=38 degree Celsius), hypotension and/or hypoxia none; G2: fever, hypotension not requiring vasopressors, hypoxia requiring low-flow nasal cannula/facemask or blow-by; G3: fever, hypotension requiring a vasopressor with or without vasopressin, hypoxia requiring high-flow nasal cannula/facemask, nonrebreather mask, or Venturi mask; G4: fever, hypotension requiring multiple vasopressors (excluding vasopressin), hypoxia requiring positive pressure. Organ toxicities associated with CRS graded according to CTCAE v5.0. G1: mild, G2: moderate, G3: severe, G4: life-threatening consequences; urgent intervention indicated. G5: death related to AE. | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSA: Number of Participants With Severity of AEs According to Immune Effector Cell-associated Neurotoxicity Syndrome ICANS Graded According to ASTCT Grading Criteria 2019- Phase 1b | ASTCT for ICANS [immune effector cell-associated encephalopathy (ICE, overall score range 0-10, higher score = better condition). G1: ICE score 7-9, awakens spontaneously; G2: ICE score 3-6, awakens to voice; G3: ICE score 0-2, awakens only to tactile stimulus, any clinical seizure that resolves rapidly or non-convulsive seizures on electroencephalography that resolve with intervention, focal/local oedema on neuroimaging; G4: ICE score 0 (unarousable and unable to perform ICE), unarousable or requires vigorous or repetitive tactile stimuli to arouse. Stupor or coma, life-threatening prolonged seizure (>5 min); or repetitive clinical or electrical seizures without return to baseline in between, deep focal motor weakness such as hemiparesis or paraparesis, diffuse cerebral oedema on neuroimaging; decerebrate or decorticate posturing; or cranial nerve VI (abducens nerve) palsy; or papilledema; or Cushing's triad; G5: death.](streamdown:incomplete-link) | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSA: Number of Participants With Laboratory Abnormalities- Phase 1b | Number of participants with laboratory abnormalities will be reported in this outcome measure. | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSA: Objective Response Rate (ORR) as Per International Myeloma Working Group (IMWG) Criteria as Determined by Investigator- Phase 1b | ORR: % of participants with objective response. Stringent complete response(sCR): CR & normal serum free light chain (sFLC) ratio &absence of clonal cells in BMB/BMA by immunohistochemistry or immunofluorescence. CR: negative immunofixation on serum &urine, disappearance of soft tissue plasmacytomas &<5% plasma cells in BMA. If disease measurable by sFLC only, preceding criteria &normal sFLC ratio. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum M-protein & urine M-protein level <100 mg/24h; PR: >=50% reduction of serum M-protein & reduction in 24h urinary M-protein by >=90% or to <200 mg/24 hours (If disease measurable by sFLC only: VGPR & PR: >=90% &>=50% decrease in difference respectively between involved & uninvolved sFLC levels). In addition, if present at baseline, VGPR & PR: >=90% &>=50% reduction compared with baseline in soft tissue plasmacytomas' size. | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSA: Complete Response Rate (CRR) as Per IMWG Criteria as Determined by Investigator- Phase 1b | CRR was defined as the percentage of participants with a Best Overall Response (BOR) of confirmed sCR/CR per IMWG response criteria as determined by investigator. sCR: i) CR; ii) normal serum FLC ratio and absence of clonal cells in BMB/BMA by immunohistochemistry or immunofluorescence (κ/λ ratio <=4:1 or >=1:2 for κ and λ participants, respectively, after counting >=100 plasma cells; iii) if the only measurable disease was by serum FLC levels, sCR was defined as normal serum FLC ratio of 0.26 to 1.65 plus absence of clonal cells in BMB/BMA b by immunohistochemistry or immunofluorescence (κ/λ ratio <=4:1 or >=1:2 for κ and λ participants, respectively, after counting >=100 plasma cells). CR: i) negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in BMA; ii) if the only measurable disease was by serum FLC levels, CR was defined as normal serum FLC ratio of 0.26 to 1.65 plus criteria (i). | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSA: Time to Response (TTR) as Per IMWG Criteria as Determined by Investigator-Phase 1b | TTR was defined, for participants with an objective response per IMWG criteria, as the time from the date of first dose to the first documentation of objective response that is subsequently confirmed. | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSA: Duration of Response (DOR) as Per IMWG Criteria as Determined by Investigator- Phase 1b | DOR (for participants (pts) with objective response (OR) per IMWG)=time from the first OR that is confirmed (conf), until conf PD per IMWG, or death due to any cause, whichever occurred first. PD=any of: (i)Increase (inc) >=25% from lowest conf response value of (a)Serum M-component (absolute (abs) inc >=0.5 g/dL) (b)Serum M-protein inc >=1 g/dL if lowest M component >=5 g/dL (c)Urine M-protein (abs inc >=200 mg/24 h) (d)in pts without measurable (meas) serum and urine M-protein levels, difference between involved and uninvolved serum FLC levels (abs inc >10 mg/dL) (e)in pts without meas serum and urine M-protein levels and without meas involved serum FLC, bone marrow plasma-cell (PC) percentage irrespective of baseline status (abs inc >=10%) (ii)appearance of new lesion(s), >=50% inc from nadir in SPD of >1 lesion, or >= 50% inc in longest diameter of a prior lesion >1 cm in short axis (iii)>=50% inc in circulating PC (minimum 200 cells per microliter) if the only measure of disease. | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSA: Duration of Complete Response (DOCR) as Per IMWG Criteria as Determined by Investigator- Phase 1b | DOCR (for participants (pts) with CR/sCR per IMWG)= time from the first CR/sCR that is confirmed (conf), until conf PD per IMWG, or death due to any cause, whichever occurred first. PD=any of: (i)Increase (inc) >=25% from lowest conf response value of (a)Serum M-component (absolute (abs) inc >=0.5 g/dL) (b)Serum M-protein inc >=1 g/dL if lowest M component >=5 g/dL (c)Urine M-protein (abs inc >=200 mg/24 h) (d)in pts without measurable (meas) serum and urine M-protein levels, difference between involved and uninvolved serum FLC levels (abs inc >10 mg/dL) (e)in pts without meas serum and urine M-protein levels and without meas involved serum FLC, bone marrow plasma-cell (PC) percentage irrespective of baseline status (abs inc >=10%) (ii)appearance of new lesion(s), >=50% inc from nadir in SPD of >1 lesion, or >= 50% inc in longest diameter of a prior lesion >1 cm in short axis (iii)>=50% inc in circulating PC (minimum 200 cells per microliter) if the only measure of disease. | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSA: Progression Free Survival (PFS) as Per IMWG Criteria as Determined by Investigator- Phase 1b | PFS=time from date of first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first. PD=any of: (i)Increase (inc) >=25% from lowest confirmed response value of (a)Serum M-component (absolute (abs) inc >=0.5 g/dL) (b)Serum M-protein inc >=1 g/dL if lowest M component >=5 g/dL (c)Urine M-protein (abs inc >=200 mg/24 h) (d)in pts without measurable (meas) serum and urine M-protein levels, difference between involved and uninvolved serum FLC levels (abs inc >10 mg/dL) (e)in pts without meas serum and urine M-protein levels and without meas involved serum FLC, bone marrow plasma-cell (PC) percentage irrespective of baseline status (abs inc >=10%) (ii)appearance of new lesion(s), >=50% inc from nadir in SPD of >1 lesion, or >= 50% inc in longest diameter of a previous lesion >1 cm in short axis (iii)>=50% inc in circulating PC (minimum 200 cells per microliter) if the only measure of disease. | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSA: Overall Survival (OS)- Phase 1b | OS was defined as the time from the first date of the study intervention to the date of death due to any cause. Participants not known to have died are censored on the date of last known alive. | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSA: Minimal Residual Disease (MRD) Negativity Rate as Per IMWG Criteria- Phase 1b | MRD negativity rate is defined as the proportion of participants with CR or better by investigator and negative MRD (assessed by central lab) per IMWG sequencing criteria at any time from the date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy, whichever occurs first. 1) CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in BMA. If the only measurable disease is by serum FLC levels, CR was defined as normal serum FLC ratio of 0.26 to 1.65; 2) Sequencing MRD-negative: Absence of clonal plasma cells by next generation sequencing (NGS) on BMA in which presence of a clone was defined as <2 identical sequencing reads obtained after DNA sequencing of BMA using the LymphoSIGHT platform (or validated equivalent method) with a minimum sensitivity of 1 in 10^5 nucleated cells. | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSA: Pre- and Post-dose Concentrations of Elranatamab- Phase 1b | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | |||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSA: Trough Serum Concentrations of Nirogacestat- Phase 1b | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | |||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSA: Number of Participants With Anti-drug Antibodies (ADA)- Phase 1b | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | |||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSA: Number of Participants With Neutralizing Antibodies (NAb)- Phase 1b | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | |||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSB: Number of Participants With TEAEs and Treatment Related TEAEs- Phase 1b | AE: any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention, including both serious and all non-serious adverse events. A SAE: any untoward medical occurrence that, at any dose resulting in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. Relatedness of any AE to treatment to be judged by investigator. | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSB: Number of Participants With Severity of Adverse Events According to CRS Graded According to ASTCT Grading Criteria 2019- Phase 1b Dose Escalation | CRS: supraphysiologic response following any immune therapy that results in the activation or engagement of endogenous or infused T-cells and/or other immune effector cells. Symptoms must include fever at the onset, and may include hypotension, hypoxia and end organ dysfunction. As per ASTCT criteria, G1: fever (temperature >=38 degree Celsius), hypotension and/or hypoxia none; G2: fever, hypotension not requiring vasopressors, hypoxia requiring low-flow nasal cannula/facemask or blow-by; G3: fever, hypotension requiring a vasopressor with or without vasopressin, hypoxia requiring high-flow nasal cannula/facemask, nonrebreather mask, or Venturi mask; G4: fever, hypotension requiring multiple vasopressors (excluding vasopressin), hypoxia requiring positive pressure. Organ toxicities associated with CRS graded according to CTCAE v5.0. G1: mild, G2: moderate, G3: severe, G4: life-threatening consequences; urgent intervention indicated. G5: death related to AE. | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSB: Number of Participants With Severity of Adverse Events According to ICANS Graded According to ASTCT Grading Criteria 2019- Phase 1b Dose Escalation | ASTCT for ICANS (ICE, overall score range 0-10, higher score = better condition). G1: ICE score 7-9, awakens spontaneously; G2: ICE score 3-6, awakens to voice; G3: ICE score 0-2, awakens only to tactile stimulus, any clinical seizure that resolves rapidly or non-convulsive seizures on electroencephalography that resolve with intervention, focal/local oedema on neuroimaging; G4: ICE score 0 (unarousable and unable to perform ICE), unarousable or requires vigorous or repetitive tactile stimuli to arouse. Stupor or coma, life-threatening prolonged seizure (>5 min); or repetitive clinical or electrical seizures without return to baseline in between, deep focal motor weakness such as hemiparesis or paraparesis, diffuse cerebral oedema on neuroimaging; decerebrate or decorticate posturing; or cranial nerve VI (abducens nerve) palsy; or papilledema; or Cushing's triad; G5: death. | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSB: Number of Participants With Laboratory Abnormalities- Phase 1b Dose Escalation | Number of participants with laboratory abnormalities will be reported in this outcome measure. | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSB: ORR as Per IMWG Criteria as Determined by Investigator- Phase 1b Dose Escalation | ORR: % of participants with objective response. sCR: CR & normal sFLC ratio and absence of clonal cells in BMB/BMA by immunohistochemistry or immunofluorescence. CR: negative immunofixation on serum and urine, disappearance of soft tissue plasmacytomas &<5% plasma cells in BMA. If disease measurable by sFLC only, preceding criteria &normal sFLC ratio. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum M-protein & urine M-protein level <100 mg/24h; PR: >=50% reduction of serum M-protein & reduction in 24h urinary M-protein by >=90% or to <200 mg/24 hours (If disease measurable by sFLC only: VGPR & PR: >=90% &>=50% decrease in difference respectively between involved & uninvolved sFLC levels). In addition, if present at baseline, VGPR & PR: >=90% &>=50% reduction compared with baseline in soft tissue plasmacytomas' size. | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSB: CRR as Per IMWG Criteria as Determined by Investigator- Phase 1b Dose Escalation | CRR was defined as the percentage of participants with a BOR of confirmed sCR/CR per IMWG response criteria as determined by investigator. sCR: i) CR; ii) normal serum FLC ratio and absence of clonal cells in BMB/BMA by immunohistochemistry or immunofluorescence (κ/λ ratio <=4:1 or >=1:2 for κ and λ participants, respectively, after counting >=100 plasma cells; iii) if the only measurable disease was by serum FLC levels, sCR was defined as normal serum FLC ratio of 0.26 to 1.65 plus absence of clonal cells in BMB/BMA b by immunohistochemistry or immunofluorescence (κ/λ ratio <=4:1 or >=1:2 for κ and λ participants, respectively, after counting >=100 plasma cells). CR: i) negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in BMA; ii) if the only measurable disease was by serum FLC levels, CR was defined as normal serum FLC ratio of 0.26 to 1.65 plus criteria (i). | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSB: TTR as Per IMWG Criteria as Determined by Investigator- Phase 1b Dose Escalation | TTR was defined for participants with an objective response per IMWG criteria, as the time from the date of first dose to the first documentation of objective response that is subsequently confirmed. | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSB: DOR as Per IMWG Criteria as Determined by Investigator- Phase 1b Dose Escalation | DOR (for participants (pts) with objective response (OR) per IMWG)=time from the first OR that is confirmed (conf), until conf PD per IMWG, or death due to any cause, whichever occurred first. PD=any of: (i)Increase (inc) >=25% from lowest conf response value of (a)Serum M-component (absolute (abs) inc >=0.5 g/dL) (b)Serum M-protein inc >=1 g/dL if lowest M component >=5 g/dL (c)Urine M-protein (abs inc >=200 mg/24 h) (d)in pts without measurable (meas) serum and urine M-protein levels, difference between involved and uninvolved serum FLC levels (abs inc >10 mg/dL) (e)in pts without meas serum and urine M-protein levels and without meas involved serum FLC, bone marrow plasma-cell (PC) percentage irrespective of baseline status (abs inc >=10%) (ii)appearance of new lesion(s), >=50% inc from nadir in SPD of >1 lesion, or >= 50% inc in longest diameter of a prior lesion >1 cm in short axis (iii)>=50% inc in circulating PC (minimum 200 cells per microliter) if the only measure of disease. | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSB: DOCR as Per IMWG Criteria as Determined by Investigator- Phase 1b Dose Escalation | DOCR (for participants (pts) with CR/sCR per IMWG)= time from the first CR/sCR that is confirmed (conf), until conf PD per IMWG, or death due to any cause, whichever occurred first. PD=any of: (i)Increase (inc) >=25% from lowest conf response value of (a)Serum M-component (absolute (abs) inc >=0.5 g/dL) (b)Serum M-protein inc >=1 g/dL if lowest M component >=5 g/dL (c)Urine M-protein (abs inc >=200 mg/24 h) (d)in pts without measurable (meas) serum and urine M-protein levels, difference between involved and uninvolved serum FLC levels (abs inc >10 mg/dL) (e)in pts without meas serum and urine M-protein levels and without meas involved serum FLC, bone marrow plasma-cell (PC) percentage irrespective of baseline status (abs inc >=10%) (ii)appearance of new lesion(s), >=50% inc from nadir in SPD of >1 lesion, or >= 50% inc in longest diameter of a prior lesion >1 cm in short axis (iii)>=50% inc in circulating PC (minimum 200 cells per microliter) if the only measure of disease. | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSB: PFS as Per IMWG Criteria as Determined by Investigator- Phase 1b Dose Escalation | PFS=time from date of first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first. PD=any of: (i)Increase (inc) >=25% from lowest confirmed response value of (a)Serum M-component (absolute (abs) inc >=0.5 g/dL) (b)Serum M-protein inc >=1 g/dL if lowest M component >=5 g/dL (c)Urine M-protein (abs inc >=200 mg/24 h) (d)in pts without measurable (meas) serum and urine M-protein levels, difference between involved and uninvolved serum FLC levels (abs inc >10 mg/dL) (e)in pts without meas serum and urine M-protein levels and without meas involved serum FLC, bone marrow plasma-cell (PC) percentage irrespective of baseline status (abs inc >=10%) (ii)appearance of new lesion(s), >=50% inc from nadir in SPD of >1 lesion, or >= 50% inc in longest diameter of a previous lesion >1 cm in short axis (iii)>=50% inc in circulating PC (minimum 200 cells per microliter) if the only measure of disease. | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSB: OS- Phase 1b Dose Escalation | OS was defined as the time from the first date of the study intervention to the date of death due to any cause. Participants not known to have died are censored on the date of last known alive. | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSB: MRD Negativity Rate as Per IMWG Criteria- Phase 1b Dose Escalation | MRD negativity rate is defined as the proportion of participants with CR or better by investigator and negative MRD (assessed by central lab) per IMWG sequencing criteria at any time from the date of first dose until the first documentation of confirmed PD, death or start of new anticancer therapy, whichever occurs first. 1) CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in BMA. If the only measurable disease is by serum FLC levels, CR was defined as normal serum FLC ratio of 0.26 to 1.65; 2) Sequencing MRD-negative: Absence of clonal plasma cells by next generation sequencing (NGS) on BMA in which presence of a clone was defined as <2 identical sequencing reads obtained after DNA sequencing of BMA using the LymphoSIGHT platform (or validated equivalent method) with a minimum sensitivity of 1 in 10^5 nucleated cells. | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSB: Pre- and Post-dose Concentrations of Elranatamab- Phase 1b Dose Escalation | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | |||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSB: Trough Serum Concentrations of Lenalidomide- Phase 1b Dose Escalation | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | |||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSA: Number of Participants With ADA- Phase 1b Dose Escalation | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants | |||||||||||||||||||||||||||||||||||||||||||
| Secondary | SSB: Number of Participants With NAb- Phase 1b Dose Escalation | Not Posted | Mar 2027 | From treatment initiation till study completion | Participants |
From first dose of study intervention and up to 90 days after last dose or start of new anticancer therapy (approximately up to 48 months)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 1 | Participants with RRMM received elranatamab 4 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) [priming dose] and thereafter 4 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID. | 1 | 2 | 1 | 2 | 2 | 2 |
| EG001 | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 2 | Participants with RRMM received elranatamab 4 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 8 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) [priming dose] and thereafter 12 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID. | 3 | 6 | 5 | 6 | 6 | 6 |
| EG002 | SSA, Phase 1b: Elranatamab + Nirogacestat,Dose Level 3 | Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) [priming dose] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID. | 3 | 10 | 6 | 10 | 10 | 10 |
| EG003 | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3A | Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) [priming dose] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally QD. | 2 | 10 | 6 | 10 | 10 | 10 |
| EG004 | SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 4A | Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) [priming dose] and thereafter 76 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally QD. | 1 | 6 | 4 | 6 | 6 | 6 |
| EG005 | SSB, Phase 1b: Elranatamab + Lenalidomide + Dexamethasone, Dose Level 1 | Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) [priming dose] and 44 mg on C0D8 and thereafter 44 mg weekly during each cycle (1 cycle = 4 weeks) and Lenalidomide 15 mg QD for 21 days and Dexamethasone 20 mg weekly on Cycle 1 and 2. | 5 | 12 | 7 | 12 | 11 | 12 |
| EG006 | All Participants | All participants who received at least one dose of study drug. | 15 | 46 | 29 | 46 | 45 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Large intestine infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA v28.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v28.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v28.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Immune effector cell-associated neurotoxicity syndrome | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Oral disorder | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Tongue disorder | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Mass | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Swelling face | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Cytomegalovirus chorioretinitis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Cytomegalovirus infection reactivation | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Enterovirus infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Herpes simplex reactivation | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Human bocavirus infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Metapneumovirus pneumonia | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Mucosal infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v28.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v28.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v28.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase decreased | Investigations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Bronchoscopy abnormal | Investigations | MedDRA v28.0 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Coronavirus test positive | Investigations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Electrocardiogram T wave inversion | Investigations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Bone lesion | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Bursal fluid accumulation | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v28.0 | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Brain fog | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Dysdiadochokinesis | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| VIth nerve paresis | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Testicular swelling | Reproductive system and breast disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Onychomadesis | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA v28.0 | Non-systematic Assessment |
|
Phase 2 of SSA was not conducted, based on sponsor's decision.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 19, 2021 | Jan 22, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C550722 | nirogacestat |
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|